Devices, systems, and methods for wound closure

ABSTRACT

A system includes a wound closure device having a shaft, proximal and distal arms coupled to the shaft, and one or more linkages coupling the proximal and distal arms. The arms are pivotable relative to the shaft between a linear position, wherein the arms and shaft are linearly aligned, a first pivoted position, wherein the proximal arm is pivoted in a first direction to pivot the distal arm in a second, opposite direction, and a second pivoted position, wherein the proximal arm is pivoted in the second direction to pivot the distal arm in the first direction. A suture including a first portion disposed about a first surface of the distal arm and a second portion disposed about a second surface of the distal aim is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of, and priority to, U.S.Provisional Patent Application No. 61/861,732, filed on Aug. 2, 2013;U.S. Provisional Patent Application No. 61/882,742, filed on Sep. 26,2013; U.S. Provisional Patent Application No. 61/882,745, filed on Sep.26, 2013; U.S. Provisional Patent Application No. 61/882,750, filed onSep. 26, 2013; U.S. Provisional Patent Application No. 61/882,754, filedon Sep. 26, 2013; U.S. Provisional Patent Application No. 61/882,758,filed on Sep. 26, 2013; and U.S. Provisional Patent Application No.61/882,759, filed on Sep. 26, 2013.

This application is related to U.S. patent application Ser. No.14/337,391, filed on Jul. 22, 2014; U.S. patent application Ser. No.14/337,465, filed on Jul. 22, 2014; U.S. patent application Ser. No.14/337,322, filed on Jul. 22, 2014; U.S. patent application Ser. No.14/337,415, filed on Jul. 22, 2014; and U.S. patent application Ser. No.14/337,491, filed on Jul. 22, 2014.

The entire contents of each of the above applications are herebyincorporated herein by reference.

BACKGROUND

Technical Field

The present disclosure relates to wound closure and, more particularly,to devices, systems, and methods for closing a wound or opening intissue.

Background of Related Art

Puncture wounds, wounds that pierce through tissue, may result fromtrauma or may be intentionally created in order to provide access to abody cavity during surgical procedures. During endoscopic surgicalprocedures, for example, a trocar device is utilized to puncture theperitoneum to provide access by way of a cannula through the abdominalwall. Generally, a trocar and/or cannula is placed through the abdominalwall for introduction of surgical instrumentation which is necessary tocarry out the surgical procedure. In this manner, the surgeon mayintroduce a surgical instrument such as a forceps, scissors, clipapplier, stapler or any other surgical instrument as desired during theparticular surgical procedure. Once the procedure is complete, it isnecessary to close the wound or opening.

SUMMARY

In accordance with the present disclosure, a wound closure system isprovided. The system includes a wound closure device including anelongated shaft defining a proximal region and a distal region. Thedistal region of the shaft is configured for insertion into an openingin tissue. A proximal arm is pivotably coupled to the shaft in theproximal region of the shaft and a distal arm is pivotably coupled toshaft in the distal region of the shaft. The distal arm defines a firstsurface and a second, opposite surface. At least one linkage extendsthrough the shaft and couples the proximal and distal arms to oneanother such that the proximal and distal arms are pivotable relative tothe shaft between a linear position, a first pivoted position, and asecond pivoted position. In the linear position, the proximal and distalarms and the shaft are linearly aligned with one another. In the firstpivoted position, the proximal arm is pivoted in a first directionrelative to the shaft to pivot the distal arm in a second, oppositedirection relative to the shaft such that the first surface ispositioned adjacent an internal surface of tissue. In the second pivotedposition, the proximal arm is pivoted in the second direction relativeto the shaft to pivot the distal arm in the first direction relative tothe shaft such that the second surface is positioned adjacent aninternal surface of tissue. That is, in the pivoted positions, the armsare angled relative to the shaft. A suture including a first portiondisposed about the first surface of the distal arm and a second portiondisposed about the second surface of the distal arm is also provided.

In embodiments, the system further includes a sleeve defining a proximalend, a distal end, a central passage extending longitudinally throughthe sleeve, and first and second needle lumens extending longitudinallythrough the sleeve on either side of the central passage. The centralpassage is configured to receive the wound closure device for removablypositioning the sleeve about the wound closure device when the woundclosure devices is disposed in the linear position. The sleeve isdistally slidable about the shaft to retain tissue between the distalend of the sleeve and the surface of the distal arm positioned adjacentan internal surface of tissue.

In embodiments, a needle is provided for insertion through the first andsecond needle lumens. The needle defines a distal portion, e.g., ahooked distal end, configured to retrieve the portion of suture disposedabout the surface of the distal arm positioned adjacent an internalsurface of tissue.

In embodiments, the needle lumens define curved configurations and theneedle defines a curved and/or flexible configuration.

In embodiments, the linkage(s) includes one or more cables coupling theproximal and distal arms to one another.

A method of closing an opening in tissue provided in accordance with thepresent disclosure includes providing a wound closure device, e.g., anyof the wound closure devices detailed above or other suitable woundclosure device. The method further includes inserting the wound closuredevice into an internal surgical site in a linear position. Next, theproximal arm is pivoted relative to the shaft in a first direction topivot the distal arm in a second, opposite direction relative to theshaft such that the first surface is positioned adjacent an internalsurface of tissue. Thereafter, a needle is inserted through tissueadjacent the opening in tissue to retrieve the first portion of sutureretained on the first surface.

In embodiments, the method further includes pivoting the proximal armrelative to the shaft in a second direction to pivot the distal arm inthe first direction relative to the shaft such that the second surfaceis positioned adjacent an internal surface of tissue on an opposite sideof the opening. The method further includes inserting a needle throughtissue adjacent the opening in tissue to retrieve the second portion ofsuture retained on the second surface.

In embodiments, the method further includes tying off the first andsecond portions of the suture to close the opening in tissue.

In embodiments, the method further includes positioning a sleeve aboutthe shaft of the wound closure device prior to pivoting the proximal armrelative to the shaft in the first direction.

In embodiments, the method further includes translating the sleevedistally about the shaft after pivoting the proximal arm relative to theshaft in the first direction to retain tissue between the sleeve and thefirst surface of the distal arm.

In embodiments, the method further includes inserting the needle througha needle lumen defined within the sleeve for guiding the needle towardsthe distal arm.

In embodiments, the method further includes providing a surgical accessdevice disposed within an opening in tissue and wherein inserting thewound closure device includes inserting the wound closure device throughthe surgical access device and into the internal surgical site in thelinear position.

In embodiments, the surgical access device is withdrawn from the openingin tissue, proximally about the wound closure device prior to pivotingthe proximal arm relative to the shaft in the first direction.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and features of the presently disclosure are describedhereinbelow with references to the drawings, wherein:

FIG. 1 is a side, perspective view of a wound closure device provided inaccordance with the present disclosure;

FIG. 2A is a longitudinal cross-sectional view of a distal portion ofthe wound closure device of FIG. 1, disposed in a retracted condition;

FIG. 2B is a longitudinal cross-sectional view of the distal portion ofthe wound closure device of FIG. 1, disposed in a deployed condition;

FIG. 3 is a side, perspective view of a surgical access deviceconfigured for use with the wound closure devices of the presentdisclosure;

FIG. 4 is a side, perspective view of a needle and sleeve assemblyconfigured for use with the wound closure device of FIG. 1;

FIG. 5A is a side, perspective view illustrating the wound closuredevice of FIG. 1 inserted through the surgical access device of FIG. 3and disposed in the retracted condition;

FIG. 5B is a side, perspective view illustrating the wound closuredevice of FIG. 1 inserted through the surgical access device of FIG. 3and disposed in the deployed condition;

FIG. 5C is a side, perspective view illustrating the wound closuredevice of FIG. 1 after removal of the surgical access device from aboutthe wound closure device;

FIG. 5D is a side, perspective view of the wound closure device of FIG.1 including the needle and sleeve assembly of FIG. 4 disposedthereabout, with the needles retracted;

FIG. 5E is a side, perspective view of the wound closure device of FIG.1 including the needle and sleeve assembly of FIG. 4 disposedthereabout, with the needles extended;

FIG. 6 is an enlarged, side, perspective view of the distal portion ofthe wound closure device of FIG. 1 including the needle and sleeveassembly of FIG. 4 disposed thereabout to define a first tissue gaptherebetween;

FIG. 7 is an enlarged, side, perspective view of the distal portion ofthe wound closure device of FIG. 1 including the needle and sleeveassembly of FIG. 4 disposed thereabout to define a second tissue gaptherebetween;

FIG. 8A is a longitudinal cross-sectional view illustrating the distalportion of the wound closure device of FIG. 1 including the needle andsleeve assembly of FIG. 4 disposed within an opening in tissue andhaving the needles deployed through tissue;

FIG. 8B is a longitudinal cross-sectional view illustrating the distalportion of the wound closure device of FIG. 1 including the needle andsleeve assembly of FIG. 4 disposed within the opening tissue, whereinthe needles have been retracted to pull the suture through tissue;

FIG. 8C is a longitudinal cross-sectional view illustrating the distalportion of the wound closure device of FIG. 1, including the needle andsleeve assembly of FIG. 4, being withdrawn from the opening in tissue;

FIG. 9 is a cross-sectional view illustrating the suture tied off toclose the opening in tissue;

FIG. 10A is a longitudinal cross-sectional view of another wound closuredevice provided in accordance with the present disclosure, disposed in aretracted condition;

FIG. 10B is a longitudinal cross-sectional view of the wound closuredevice of FIG. 10A, disposed in a deployed condition;

FIG. 11A is a side view of another wound closure device provided inaccordance with the present disclosure, disposed in a retractedcondition;

FIG. 11B is a perspective view of the wound closure device of FIG. 11A,disposed in a deployed condition;

FIG. 12 is an enlarged, perspective view of the distal portion of thewound closure device of FIG. 11A, disposed in the deployed condition;

FIG. 13 is an enlarged, perspective view of the area of detail indicatedas “13” in FIG. 12;

FIG. 14 is a top view of a four-legged suture provided in accordancewith the present disclosure and configured for use with the woundclosure device of FIG. 11A;

FIG. 15A is a side, perspective view of another wound closure deviceprovided in accordance with the present disclosure, disposed in aretracted condition;

FIG. 15B is a side, perspective view of the wound closure device of FIG.15A, disposed in a deployed condition and including a suture grasperextending therethrough;

FIG. 16 is an enlarged, perspective view of the distal portion of thewound closure device of FIG. 15A, disposed in the retracted conditionand including a replaceable cartridge mounted therein;

FIG. 17 is an enlarged, perspective view of the distal portion of thewound closure device of FIG. 15A, disposed in the deployed conditionwith the replaceable cartridge mounted therein and the suture grasperextending therethrough;

FIG. 18A is a side, perspective view of the replaceable cartridge,disposed in a retracted condition;

FIG. 18B is a side, perspective view of the replaceable cartridge,disposed in a deployed condition;

FIG. 19A is a side, perspective view of another suture grasper providedin accordance with the present disclosure, disposed in a penetratingcondition;

FIG. 19B is a side, perspective view of the suture grasper of FIG. 19A,disposed in an open condition;

FIG. 19C is a side, perspective view of the suture grasper of FIG. 19A,disposed in an extended condition;

FIG. 19D is a side, perspective view of the suture grasper of FIG. 19A,disposed in a grasping condition;

FIG. 20A is an enlarged, side, perspective view of the distal portion ofthe wound closure device of FIG. 15A including the suture grasper ofFIG. 19A extending therethrough in the penetrating condition;

FIG. 20B is an enlarged, side, perspective view of the distal portion ofthe wound closure device of FIG. 15A including the suture grasper ofFIG. 19A extending therethrough in the open condition;

FIG. 20C is an enlarged, side, perspective view of the distal portion ofthe wound closure device of FIG. 15A including the suture grasper ofFIG. 19A extending therethrough in the extended condition;

FIG. 20D is an enlarged, side, perspective view of the distal portion ofthe wound closure device of FIG. 15A including the suture grasper ofFIG. 19A extending therethrough in the grasping condition;

FIG. 21 is a side view of a distal portion of another wound closuredevice provided in accordance with the present disclosure;

FIG. 22 is a side, perspective view of the wound closure device of FIG.21;

FIG. 23 is a side view of a distal portion of another wound closuredevice provided in accordance with the present disclosure;

FIG. 24 is a longitudinal cross-sectional view of a locking collarprovided in accordance with the present disclosure and shown in use inconjunction with the wound closure device of FIG. 21;

FIG. 25A is a longitudinal cross-sectional view of another lockingcollar provided in accordance with the present disclosure and shown inuse in conjunction with the wound closure device of FIG. 21;

FIG. 25B is a transverse cross-sectional view along section line“25B-25B” of FIG. 25A;

FIG. 26 is a side, perspective view of another suture grasper providedin accordance with the present disclosure;

FIG. 27 is a longitudinal cross-sectional view of the suture grasper ofFIG. 26 including a suture member mounted therein;

FIG. 28 is a side view of a distal end of another wound closure deviceprovided in accordance with the present disclosure retaining a portionof a suture thereon;

FIG. 29A is a side, perspective view of another suture grasper providedin accordance with the present disclosure, wherein the plunger of thesuture grasper is disposed in a proximal position;

FIG. 29B is a side, perspective view of the suture grasper of FIG. 29A,wherein the plunger of the suture grasper is disposed in a distalposition;

FIG. 30 is a side view of a distal portion of another wound closuredevice provided in accordance with the present disclosure including areplaceable suture member mounted thereon;

FIG. 31 is a side view of one of the arms of the wound closure device ofFIG. 30 including the replaceable suture member removed thereform;

FIG. 32 is a side view of a distal portion of another suture grasperprovided in accordance with the present disclosure and configured foruse with the wound closure device of FIG. 30;

FIG. 33 is a side view of a distal portion of another wound closuredevice provided in accordance with the present disclosure retaining aportion of a suture thereon;

FIG. 34 illustrates a suture member and distal portion of acorresponding suture grasper provided in accordance with the presentdisclosure;

FIG. 35 illustrates another suture member and distal portion of acorresponding suture grasper provided in accordance with the presentdisclosure;

FIG. 36 illustrates another suture member and distal portion of acorresponding suture grasper provided in accordance with the presentdisclosure;

FIG. 37 is a side view of another wound closure device provided inaccordance with the present disclosure, disposed in a linear condition;

FIG. 38 is a side view of the wound closure device of FIG. 37, disposedin an articulated condition;

FIG. 39 is a side view of the wound closure device of FIG. 37, disposedin the articulated condition and including a suture grasper insertedtherethrough;

FIG. 40 is a side, perspective view of the suture grasper illustrated inFIG. 39;

FIG. 41 is an enlarged, longitudinal cross-sectional view of a distalend of the wound closure device of FIG. 37, disposed in the articulatedcondition and including the suture grasper of FIG. 40 insertedtherethrough;

FIG. 42 is a side, perspective view of another wound closure deviceprovided in accordance with the present disclosure;

FIG. 43A is a longitudinal cross-sectional view of a distal portion ofthe wound closure device of FIG. 42, disposed in a retracted position;

FIG. 43B is a longitudinal cross-sectional view of a distal portion ofthe wound closure device of FIG. 42, disposed in a deployed position;

FIG. 44A is a top view of one of the arms of the wound closure device ofFIG. 42 retaining a portion of suture thereon;

FIG. 44B is a side view of the arm of FIG. 44A retaining a portion ofsuture thereon;

FIG. 45A is a longitudinal cross-sectional view of another wound closuredevice provided in accordance with the present disclosure, positionedwithin an opening in tissue and disposed in a retracted condition; and

FIG. 45B is a longitudinal cross-sectional view of the wound closuredevice of FIG. 45A, positioned within an opening in tissue and disposedin a deployed condition.

DETAILED DESCRIPTION OF THE EMBODIMENTS

In the figures and in the description that follows, in which likereference numerals identify similar or identical elements, the term“proximal” will refer to the end of the apparatus or portion thereofwhich is closest to the operator during use, while the term “distal”will refer to the end or portion which is farthest from the operator, asis traditional.

Turning to FIGS. 1-2B, a wound closure device provided in accordancewith the present disclosure is shown generally as wound closure device100. Wound closure device 100 includes an elongated shaft 110 definingproximal and distal regions 111 a, 111 b, respectively, and alongitudinal axis “X-X.” A plunger 120 is slidably received within shaft110 and extends longitudinally through shaft 110. A pair of selectivelydeployable arms 130, 140 is operably coupled to both shaft 110 andplunger 120 at distal region 111 b of shaft 110. A suture 150 isoperably coupled to wound closure device 100 and includes a intermediateportion 152 extending proximally from plunger 120 and shaft 110, a bodyportion 154 extending distally through plunger 120 and shaft 110, andfirst and second ends 156, 158 retained via first and second deployablearms 130, 140, respectively. First and second ends 156, 158 of suture150 may defined a looped configuration formed via a cinch-knot, or anyother suitable looped or other non-looped configuration. A pair ofrouting members 116, 117 is positioned in distal region 111 b of shaft110 and configured to route first and second ends 156, 158 of suture 150from plunger 120, about routing members 116, 117, to the respectivefirst and second arms 130, 140.

Shaft 110 is configured for insertion through an opening in tissue,e.g., wound, incision, or a naturally occurring orifice, such thatdistal region 111 b of shaft 110 extends through the opening into aninternal body cavity of the patient to allow for deployment of arms 130,140 within the internal body cavity, while proximal region 111 a ofshaft 110 remains externally positioned relative to the opening tofacilitate manipulation and/or actuation of wound closure device 100.Shaft 110 defines a longitudinal bore 112 extending therethrough. Bore112 is configured to slidably receive plunger 120. Shaft 110 alsoincludes first and second opposed cut-outs 113, 114 defined within theexterior surface of shaft 110 towards distal region 111 b thereof for atleast partially receiving arms 130, 140, respectively, when arms 130,140 are disposed in the retracted position (FIG. 2A). As can beappreciated, such a feature reduces the maximum radial dimension ofshaft 110 when arms 130, 140 are disposed in the retracted position(FIG. 2A) to facilitate insertion and removal of shaft 110 through theopening in tissue.

Arms 130, 140 are pivotably coupled to shaft 110 via pivot pins 131, 141and are disposed in distal region 111 b of shaft 110. Pivoting ends 132,142 of arms 130, 140 each define a pinion member 133, 143 including aplurality of radially-disposed gear teeth 134, 144. Arms 130, 140 extendfrom pivoting ends 132, 142 to free ends 135, 145, respectively.Suture-retaining voids 136, 146 are defined within arms 130, 140proximate free ends 135, 145, respectively. First and second ends 156,158 of suture 150 may be releasably retained on arms 130, 140 adjacentto or within suture-retaining voids 136, 146 via adhesives,friction-fitting within slots defined about suture-retaining voids 136,146 (see FIG. 13, for example), or in any other suitable fashion such asvia any of the configurations detailed hereinbelow. Suture-retainingvoids 136, 146, as will be described in greater detail hereinbelow, areconfigured for receiving needles 316, 318 (FIG. 4), respectively, tofacilitate retrieval of first and second ends 156, 158 of suture 150from arms 130, 140, and proximal withdrawal of first and second ends156, 158 of suture 150 through tissue adjacent the opening in tissue.

Plunger 120, as mentioned above, is slidably received within shaft 110.More specifically, plunger 120 has an elongated rod 122 that is slidablyreceived within longitudinal bore 112 defined through shaft 110. Rod 122extends proximally from bore 112 of shaft 110 to an actuator member 124disposed at the proximal end of rod 122. Actuator member 124 isconfigured to facilitate actuation of plunger 120. A gear rack 126 isdisposed at the distal portion of rod 122. Gear rack 126 defines firstand second linear gear-tooth segments 127 a, 127 b positioned adjacentrespective first and second arms 130, 140 in meshed engagement withradially-disposed gear teeth 134, 144 of pinion members 133, 143 of arms130, 140, respectively, such that distal translation of rod 122 throughbore 112 and relative to arms 130, 140 effects rotation of arms 130, 140relative to shaft 112 from the deployed position (FIG. 2B) to theretracted position (FIG. 2A), and such that proximal translation of rod122 through bore 112 and relative to arms 130, 140 effects rotation ofarms 130, 140 relative to shaft 112 from the retracted position (FIG.2A) to the deployed position (FIG. 2B). Plunger 120 may be biasedtowards a proximal position such that arms 130, 140, in turn, are biasedtowards the deployed position (FIG. 2B), similarly as described belowwith respect to wound closure device 400 (FIGS. 10A-10B). Other biasedconfigurations, or no biasing of arms 130, 140, are also contemplated.

Turning now to FIG. 3, an exemplary surgical access device configuredfor use with wound closure device 100 (FIG. 1), or any of the otherwound closure devices provided in accordance with the presentdisclosure, is shown designated as surgical access device 200. Surgicalaccess device 200 generally includes a proximal housing 210 and anelongated body 220 extending distally from proximal housing 210.Surgical access device 200 is configured for insertion into an openingin tissue such that proximal housing 210 is positioned proximallyadjacent the opening, i.e., externally, while elongated body 220 extendsdistally though the opening and into the internal body cavity. Surgicalaccess device 200 may include an inflation port (not shown) and one ormore seal members (not shown) configured to facilitate insufflation ofthe internal body cavity and to maintain the internal body cavity in aninsufflated state during use, e.g., during insertion, manipulation,and/or withdrawal of surgical instrumentation through access device 200.Any other suitable surgical access device may likewise be provided foruse in accordance with the present disclosure.

With reference to FIG. 4, a needle and sleeve assembly provided inaccordance with the present disclosure and configured for use with woundclosure device 100 (FIG. 1) is shown designated as needle and sleeveassembly 300. Needle and sleeve assembly 300 includes a needle assembly310 and a sleeve 320. Needle assembly 310 includes a base member 312defining a central aperture 314 configured to slidably receive shaft 110of wound closure device 100 and is dimensioned to be complementary toshaft 110 (see FIG. 1). Needle assembly 310 further includes a pair ofneedles 316, 318 extending distally from base member 312 on either sideof central aperture 314. Each needle 316, 318 defines a hooked or“J”-shaped distal end 317, 319 (FIG. 5E), although other configurationsare also contemplated.

Continuing with reference to FIG. 4, sleeve 320 of needle and sleeveassembly 300 includes a body 322 having a proximal collar 324 and abifurcated distal end 326 defining first and second fingers 327, 328angled outwardly from body 322 and from one another. A centralpassageway 330 is configured to slidably receive shaft 110 of woundclosure device 100 and dimensioned complementary to shaft 110 (see FIG.1). Central passageway 330 extends longitudinally through proximalcollar 324 and body 322 of sleeve 320. Proximal collar 324 includes apair of opposed flexible ratchet tabs 332 pivotably disposed on proximalcollar 324 to define opposed surfaces within central passageway 330.Teeth 333 of ratchet tabs 332 are configured to incrementally engageindentations 115 located on shaft 110 of wound closure device 100 toinhibit sleeve 320 from moving proximally as sleeve 320 is translateddistally about shaft 110 of wound closure device 100 (see FIG. 1). Inorder to disengage teeth 333 from indentations 115, ratchet tabs 332 areflexed inwardly to displace teeth 333 from indentations 115, thusallowing sleeve 320 to be returned proximally. Body 322 further definesfirst and second needle lumens 334, 335 extending through proximalcollar 324 on either side of passageway 330, through body 322, and firstand second fingers 327, 328, respectively. Needle lumens 334, 335, aswill be described in greater detail below, are configured to guidetranslation of needles 316, 318 through sleeve 320 and to direct needles316, 318 towards suture-retaining voids 136, 146 of arms 130, 140 (FIG.2B).

Turning now to FIGS. 5A-9, the use and operation of wound closure device100, in conjunction with surgical access device 200 and needle andsleeve assembly 300, for closing an opening in tissue is described. Asmentioned above, surgical access device 200 is typically utilized duringa minimally-invasive surgical procedure to maintain the internal bodycavity in an insufflated state during use and/or to facilitate theinsertion, manipulation, and/or withdrawal of surgical instrumentationthrough access device 200 during the course of the surgical procedure.

Referring to FIGS. 5A-5C, when it is desired to close the opening intissue, wound closure device 100 is inserted into through access device200 with arms 130, 140 disposed in the retracted position, as shown inFIG. 5A. More specifically, prior to insertion, actuator member 124 ofplunger 120 is depressed relative to shaft 110 to in order to rotatearms 130, 140 from the deployed position to the retracted position.Thus, with wound closure device 100 disposed in the retracted condition,wound closure device 100 may be inserted through access device 200 suchthat distal region 111 b of shaft 110 of wound closure device 100extends distally from access device 200 into the internal surgical site,while proximal region 111 a of shaft 110 remains proximally of accessdevice 200 and external to tissue. Once wound closure device 100 hasbeen inserted through access device 200, actuator member 124 may bereturned proximally relative to shaft 110 (or released, in embodimentswhere arms 130, 140 are biased towards the deployed position) to returnarms 130, 140 to the deployed position, as shown in FIG. 5B. Thereafter,access device 200 may be withdrawn from the opening in tissue aboutwound closure device 100 (see FIG. 5C). More specifically, as theportion of wound closure device 100 disposed within and extendingproximally from access device 200 defines a substantially uniform radialdimension, withdrawal of access device 200 about wound closure device100 can be readily effected.

With reference to FIG. 5D, once access device 200 (FIGS. 5A-5B) has beenwithdrawn, sleeve 320 may be disposed about wound closure device 100 andslid distally about shaft 110 of wound closure device 100 until firstand second fingers 327, 328 of sleeve 320 are positioned proximallyadjacent to or partially extending into the opening in tissue, as shownin FIG. 5D. The particular positioning of first and second fingers 327,328 of sleeve 320 relative to tissue may depend on the procedure beingperformed, the location of the opening in tissue, the patient's anatomy,the user's preference, and/or other factors. For some procedures, it hasbeen found that extending sleeve 320 through the skin and fatty layersof tissue such that first and second fingers 327, 328 are positionedproximally adjacent the fascia and muscle layers of tissue isadvantageous in that fascia and muscle layers are better suited toreceive and retain a suture for closing the opening in tissue.

Continuing with reference to FIG. 5D, as sleeve 320 is slid distallyabout shaft 110 of wound closure device 100, ratchet tabs 332 ofproximal collar 324 of sleeve 320 incrementally engage indentations 115of shaft 110 to inhibit sleeve 320 from moving proximally. Further, thecomplementary configuration of central passageway 330 of body 322 ofsleeve 320 relative to shaft 110 of wound closure device 100 ensuresalignment of first and second fingers 327, 328 relative to first andsecond arms 130, 140, respectively. Sleeve 320 is translated distallyalong shaft 110 until the desired portion of tissue adjacent the openingis held or positioned between arms 130, 140 and fingers 327, 328.

Once sleeve 320 is positioned as desired, or prior thereto, base member312 of needle assembly 310 is disposed about shaft 110 and slid distallyabout shaft 110 such that needles 316, 318 extend partially into, butnot distally from, needle lumens 334, 335 (FIG. 8A) of sleeve 320. Thecomplementary configuration of aperture 314 of base member 312 relativeto shaft 110 ensures alignment of needles 316, 318 relative to needlelumens 334, 335 (FIG. 8A). With additional reference to FIG. 5E, withsleeve 320 and arms 130, 140 positioned such that tissue to be suturedis disposed therebetween, needle assembly 310 may be advanced furtherdistally relative to shaft 110 and sleeve 320 such that needles 316, 318extend from needle lumens 334, 335, through the tissue disposed betweensleeve 320 and arms 130, 140, and into suture-retaining voids 136, 146(FIG. 8A) of arms 130, 140.

Referring momentarily to FIGS. 6 and 7, as can be appreciated, dependingon the thickness of tissue to be sutured, anatomical considerations,etc., sleeve 320 may be positioned more-distally, e.g., as in FIG. 6, ormore-proximally, e.g., as in FIG. 7, to vary the gap distance “G”between fingers 327, 328 and arms 130, 140, respectively. As mentionedabove, ratchet tabs 332 of proximal collar 324 of sleeve 320, inconjunction with indentations 115 of shaft 110 of wound closure device100, allow for the user to set a desired gap distance “G” betweenfingers 327, 328 and arms 130, 140, respectively. Further, indicia orother visual markings may be provided on shaft 110 to allow the user toreadily ascertain the gap distance “G.”

Referring again to FIG. 5E, and with additional reference to FIG. 8A,needles 316, 318 are advanced through tissue into suture-retaining voids136, 146 of arms 130, 140, respectively, sufficiently such that hookeddistal ends 317, 319 of needles 316, 318 extend through and distallybeyond first and second looped ends 156, 158 of suture 150. Once needles316, 318 have been extended in this manner, the user may graspintermediate portion 152 of suture 150, which extends proximally fromplunger 120 and shaft 110, and translate suture 150 proximally. Morespecifically, suture 150 is translated proximally with sufficient urgingsuch that looped ends 156, 158 of suture 150 are disengaged from arms130, 140 and are cinched or otherwise held against needles 316, 318, asshown in FIG. 8A.

With additional reference to FIG. 8B, with ends 156, 158 of suture 150cinched or held about needles 316, 318, needles 316, 318 may beretracted by translating base member 312 proximally relative to sleeve320 until distal ends 317, 319 (FIG. 5E) of needles 316, 318 areretracted into needle lumens 334, 335 of sleeve 320. Retraction ofneedles 316, 318 catches first and second ends 156, 158 of suture 150with respective distal ends 317, 319 (FIG. 5E) of needles 316, 318 suchthat first and second ends 156, 158 of suture 150 are pulled proximallythrough tissue and into needle lumens 334, 335 of sleeve 320. As can beappreciated, with suture 150 routed above distal region 111 b of shaft110 via routing members 116, 117, the above-detailed proximal movementof ends 156, 158 of suture 150 pulls intermediate portion 152 of suture150 distally through wound closure device 100 and the opening in tissue(see FIG. 8C).

Referring additionally to FIGS. 8C and 9, once needles 316, 318 havebeen retracted and ends 156, 158 of suture 150 pulled proximally throughtissue, arms 130, 140 of wound closure device 100 may be moved to theretracted position, e.g., via depressing actuator member 124 of plunger120 (FIG. 5A). Thereafter, wound closure device 100, along with sleeve320 (together or independently of one another), may be withdrawn fromthe opening in tissue, leaving suture 150 with a “U”-shapedconfiguration (FIG. 9) in tissue. In this configuration, ends 156, 158of suture 150 extend proximally through tissue on either side of theopening and intermediate portion 152 of suture 150 extends across theopening on an internal side of tissue. With suture 150 in thisconfiguration, ends 156, 158 may be tied off to close the opening intissue (see FIG. 9).

Referring to FIGS. 10A and 10B, another wound closure device provided inaccordance with the present disclosure is shown designated as woundclosure device 400. Wound closure device 400 includes an elongated shaft410, a plunger 420 slidably received within shaft 410 and extendinglongitudinally through shaft 410, and a pair of selectively deployablearms 430, 440 pivotably coupled to shaft 410. Similar to wound closuredevice 100 (FIG. 1), a suture 450 is operably coupled to wound closuredevice 400 such that an intermediate portion 452 extends proximally fromplunger 420 and shaft 410, a body portion 454 extends distally throughplunger 420 and shaft 410, and first and second ends 456, 458 areretained via first and second deployable arms 430, 440, respectively.Unless specifically contradicted hereinbelow, wound closure device 400may incorporate any of the features of wound closure device 100 (FIG.1), detailed above, and vice versa.

With continued reference to FIGS. 10A-10B, shaft 410 defines a centralbore 411 extending longitudinally therethrough that is configured toslidably receive plunger 420. A chamber 412 is positioned at theproximal end of bore 411 in communication with bore 411. Chamber 412defines an increased diameter as compared to bore 411. A biasing member414 is positioned within chamber 412 and is inhibited from extendingdistally into bore 411 due to the reduced diameter of bore 411 ascompared to chamber 412. A proximal end recess 415 defined within shaft410 and disposed in communication with chamber 412 is configured toreceive collar 425 of plunger 420 when plunger 420 is disposed in thedepressed position (FIG. 10A). Shaft 410 further includes, similar toshaft 110 of wound closure device 100 (FIG. 1), first and second opposedcut-outs 416, 417 defined within the exterior surface of shaft 410proximate the distal region thereof for at least partially receivingarms 430, 440, respectively, when arms 430, 440 are disposed in theretracted position (FIG. 10A).

Arms 430, 440 define pivoting ends 423, 442 adjacent respective pivotpins 431, 441. Pivoting ends 432, 442 of arms 430, 440 each define anangled cam surface 433, 443, the importance of which will be describedin greater detail hereinbelow. Arms 430, 440 extend from pivoting ends432, 442 to free ends 435, 445, respectively, that are configured toreleasably retain the respective first and second ends 456, 458 ofsuture 450. Arms 430, 440 further include slots 436, 446 configured toroute the respective first and second ends 456, 458 of suture 450 fromthe distal region of plunger 420 to free ends 435, 445 of arms 430, 440,respectively. Arms 430, 440 may be biased towards the deployed position(FIG. 10B), e.g., via torsion springs (not shown) disposed about pivotpins 431, 441 or in any other suitable manner.

Plunger 420 includes an elongated rod 422 that is slidably receivedwithin central bore 411 defined through shaft 410. Plunger 420 furtherincludes an actuator member 424 having a collar 425 attached to a distalend thereof. Rod 422 extends distally from collar 425. Collar 425, asmentioned above, is configured for receipt within proximal end recess415 of shaft 410 when plunger 420 is disposed in the depressed position(FIG. 10A). Rod 422 extends through biasing member 414 with biasingmember 414 retained between collar 425 and the shoulder defined at theinterface between chamber 412 and bore 411. As such, biasing member 414biases collar 425 and, thus, plunger 420 proximally relative to shaft410 (FIG. 10B).

A distal end cap 426 is disposed at the distal end of rod 422. Morespecifically, rod 422 extends distally through bore 411 and distally ofpivot pins 431, 441 such that distal end cap 426 is positioned distallyof and in contact with pivoting ends 432, 442 of arms 430, 440. In thedepressed position of plunger 420, rod 422 extends further distallyrelative to arms 430, 440 such that distal end cap 426 is spaceddistally from arms 430, 440, allowing arms 430, 440 to assume thedeployed position (FIG. 10B) under bias of the torsion springs (notshown) or other suitable biasing mechanism. In the released position ofplunger 420, distal end cap 426 is moved proximally, e.g., under thebias of biasing member 414, such that cam surfaces 428 of distal end cap426 contact angled cam surfaces 433, 443 of arms 430, 440 to urge arms430, 440 to pivot about pivot pins 431, 441 from the retracted position(FIG. 10A) to the deployed position (FIG. 10B). More specifically, theorientation of angled cam surfaces 433, 443 relative to cam surface 428and the positioning of angled cam surfaces 433, 443 on the opposite sideof pivot pins 431, 441 as compared to free ends 435, 445 of arms 430,440, allow cam surfaces 428 of distal end cap 426 to urge arms 430, 440to pivot about pivot pins 431, 441 from the retracted position (FIG.10A) to the deployed position (FIG. 10B) as distal end cap 426 istranslated proximally relative to shaft 410 under the bias of biasingmember 414. Distal end cap 426 further defines a lumen configured toroute first and second ends 456, 458 of suture 450 distally through endcap 426 to the respective first and second arms 430, 440.

The use and operation of wound closure device 400 is similar to thatdetailed above with respect to wound closure device 100 (FIG. 1). Thatis wound closure device 400 may be used in conjunction with surgicalaccess device 200 and needle and sleeve assembly 300 for closing anopening in tissue, similarly as detailed above with respect to FIGS.5A-9. Alternatively, wound closure device 400 may be used in conjunctionwith any other suitable suture retrieval device and/or access device,e.g., any of those detailed hereinbelow.

Referring to FIGS. 11A-13, another wound closure device provided inaccordance with the present disclosure is shown designated as woundclosure device 500. With reference to FIGS. 11A and 11B, wound closuredevice 500 includes an elongated tubular member 502, an elongated shaft510 extending longitudinally through tubular member 502, a plunger 520slidably received within shaft 510 and extending longitudinally throughshaft 510, an actuator sleeve 530 slidably disposed about an annularlyrecessed proximal region 503 a of elongated tubular member 502, and anend cap 540 disposed at the distal end of shaft 510 that includes four(4) selectively deployable arms 542. Similar to wound closure device 400(FIGS. 10A and 10B), a suture 550 is operably coupled to wound closuredevice 500 such that an intermediate portion 552 extends proximally fromplunger 520 and shaft 510, and a body portion (not shown) extendsdistally through plunger 520 and shaft 510. However, rather thanproviding two ends as with respect to wound closure device 400 (FIGS.10A-10B), suture 550 defines four (4) ends 555, 556, 557, 558 (FIG. 12),e.g., via adjoining, knotting, braiding, etc. multiple sutures (orproviding two or more separate sutures), each of which is retained viaone of the deployable arms 542. Unless specifically contradictedhereinbelow, wound closure device 500 may incorporate any of thefeatures of wound closure devices 100, 400 (FIGS. 1 and 10A-10B,respectively), detailed above, and vice versa.

With continued reference to FIGS. 11A-11B, shaft 510 defines a centralbore (not explicitly shown) extending longitudinally therethrough thatis configured to slidably receive the shaft of plunger 520, similarly asdetailed above with respect to wound closure devices 100, 400 (FIGS. 1and 10A-10B, respectively). End cap 540 is engaged to shaft 510 at thedistal end of shaft 510 and, as mentioned above, includes four (4)selectively deployable arms 542 symmetrically disposed about shaft 510.Arms 542 are pivotably coupled to end cap 540 and are pivotable relativeto end cap 540 between a retracted position (FIG. 11A) and a deployedposition (FIG. 11B). Arms 542 will be described in greater detailhereinbelow.

Plunger 520 has an actuator 522 disposed at the proximal end of plunger520. A rod of plunger 520 extends distally into end cap 540 and isoperably coupled to arms 542 such that proximal translation of plunger520 through and relative to shaft 510 effects pivoting of arms 542 fromthe retracted position (FIG. 11A) to the deployed position (FIG. 11B).More specifically, the rod of plunger 520 may be coupled to arms 542 inany suitable fashion for this purpose such as, for example, via a rackand pinion coupling, similarly are described above with respect to woundclosure device 100 (FIG. 1), or via a cam surface coupling, similarly asdescribed above with respect to wound closure device 400 (FIGS. 10A and10B). Further, a biasing member 526 disposed within a chamber thatcommunicates with the bore (not shown) of shaft 510 is provided to biasplunger 520 proximally, thus biasing arms 542 towards the retractedposition (FIG. 11A), similarly as detailed above with respect to woundclosure device 400 (FIGS. 10A and 10B).

Elongated tubular member 502 is disposed about shaft 510 and extendssubstantially along the length of shaft 510. However, shaft 510 extendsfurther distally relative to elongated tubular member 502 such thatelongated tubular member 502 is spaced-apart from the distal end ofshaft 510 and end cap 540. As a result of this configuration, arms 542may be closely approximated with shaft 510 when disposed in theretracted position (FIG. 11A), thereby defining a low-profileconfiguration. More specifically, in the retracted position, arms 542 donot extend beyond the outer radial dimension of elongated tubular member502 to facilitate insertion and removal of wound closure device 500through the opening in tissue.

Elongated tubular member 502 includes four (4) needle lumens 504extending therethrough. Needle lumens 504 exit elongated tubular member502 at four (4) equally-spaced openings 506 radially disposed about theouter peripheral surface of elongated tubular member 502 near the distalregion thereof. Each opening 506 is positioned and oriented towards oneof the arms 542 when arms 542 are disposed in the deployed position(FIG. 11B). Needle lumens 504 are radially disposed about shaft 510 andextend in generally parallel orientation relative to elongated tubularmember 502 substantially along their lengths. However, the distal endsof needle lumens 504 define annular or helical configurations such thateach lumen 504 communicates with one of the openings 506 defined withinelongated tubular member 502.

Continuing with reference to FIGS. 11A-11B, a needle assembly isintegrally provided with wound closure device 500. The needle assemblyincludes an actuator sleeve 530 slidably mounted about annularlyrecessed proximal region 503 a of elongated tubular member 502 between adistal body portion 503 b thereof and a proximal collar 503 c thereof.The needle assembly further includes four (4) suture-retrieving needles562 coupled to actuator sleeve 530 and slidably received within needlelumens 504 to move in conjunction with actuator sleeve 530. Each needle562 defines a hooked or “J”-shaped distal end 563, although otherconfigurations are also contemplated. Actuator sleeve 530 is slidableabout annularly recessed proximal region 503 and relative to elongatedtubular member 502 from a proximal position, corresponding to a storageposition of needles 562, wherein needles 562 are fully disposed withinlumens 504 (FIG. 11A), and a distal position, corresponding to anextended position of needles 562, wherein each needle 562 extendsradially outwardly and distally from one of the openings 506 towards oneof the arms 542 (FIG. 11B). Actuator sleeve 530 defines a low-profileconfiguration relative to distal body portion 503 b of elongated tubularmember 502 to facilitate removal of surgical access device 200 (FIG. 3)about wound closure device 500, similarly as detailed above. Woundclosure device 500 may further include a handle (not shown) fixedlyengaged to elongated tubular member 502 to facilitate sliding ofactuator sleeve 530 relative to elongated tubular member 502 between theproximal and distal positions, e.g., via grasping both the handle andactuator sleeve 530 and sliding actuator sleeve 530 relative to thehandle, and/or facilitating depression of actuator 522 relative toelongated tubular member 502, e.g., via grasping both the handle andactuator 522 and depressing actuator 522 relative to the handle.Alternatively or additionally, actuator sleeve 530 may be configured torotate, e.g., 90 degrees, about elongated tubular member 502 between alocked position, wherein actuator sleeve 530 is fixed relative toelongated tubular member 502, e.g., to facilitate actuation of actuator522, and an unlocked position, wherein actuator sleeve 530 is slidableabout elongated tubular member 502, e.g., to permit actuation ofactuator sleeve 530.

Referring additionally to FIGS. 12-13, each arm 542 defines asuture-retaining void 543 near the free end thereof. Annular slots 545are defined about the inner surfaces of arms 542 that definesuture-retaining voids 543. Each arm 542 further defines a linear slot547 configured to route the ends 555, 556, 557, 558 of suture 550 fromend cap 540 to the free ends of arms 542. The ends 555, 556, 557, 558 ofsuture 550 are looped about voids 543 and retained in position viaengagement within annular slots 545. As such, needles 562 are insertableinto voids 543 and through looped ends 555, 556, 557, 558, respectively,of suture 550. Openings 506 are positioned and oriented to directneedles 562 towards arms 542 such that, upon extension of needles 562,the hooked distal ends 563 of needles 562 extend into voids 543, asshown in FIGS. 12 and 13.

In use, similarly as detailed above with respect to wound closure device100 (FIG. 1), wound closure device 500 is transitioned to the retractedposition, e.g., via depression of actuator 522 relative to elongatedtubular member 502, and is inserted into through an access device 200(FIG. 3) positioned within an opening in tissue. Wound closure device500 is capable of being used with access device 200 (FIG. 3) in that thelow-profile configuration of wound closure device 500 allows accessdevice 200 (FIG. 3) to be withdrawn about wound closure device 500,similarly as detailed above with respect to wound closure device 100(FIG. 5A). However, it is also contemplated that wound closure device500 be utilized without an access device 200 (FIG. 3), e.g., woundclosure device 500 may be inserted after withdrawal of access device 200(FIG. 3) from the opening in tissue.

Once wound closure device 500 has been inserted and access device 200(FIG. 3) removed, actuator 522 may be released, allowing arms 542 toreturn under bias, to the deployed position. Alternatively, accessdevice 200 (FIG. 3) may be removed after deployment of arms 542. Witharms 542 deployed, wound closure device 500 may be manipulated such thatthe desired portion of tissue to be sutured is positioned betweenopenings 506 defined within elongated tubular member 502 and arms 542.Next, actuator sleeve 530 is slid distally about annularly recessedproximal region 503 a of elongated tubular member 502, e.g., viagrasping actuator sleeve 530 and elongated tubular member 502 (or ahandle (not shown) affixed thereto) and translating actuator sleeve 530distally relative to elongated tubular member 502 to move needles 562from the storage position, wherein needles 562 are fully disposed withinlumens 504 (FIG. 11A), to the extended position, wherein needles 562extend through tissue into a respective one of the suture-retainingvoids 543 of arms 542 (see FIG. 13).

Once needles 562 have been advanced through tissue and intosuture-retaining voids 543, the user may grasp intermediate portion 552of suture 550 (FIGS. 11A and 11B) and translate suture 550 proximallywith sufficient urging such that ends 555, 556, 557, 558 of suture 550are disengaged from annular slots 545 and are cinched or otherwise heldagainst needles 562. Once ends 555, 556, 557, 558 of suture 550 arecinched or held about needles 562, needles 562 may be retracted viaproximal sliding of actuator sleeve 530 about annularly recessedproximal region 503 a of elongated tubular member 502. As actuatorsleeve 530 is slid proximally relative to elongated body 502, needles562 are likewise translates proximally relative to elongated body 502 tocatch ends 555, 556, 557, 558 of suture 550 with hooked distal ends 563of needles 562. Needles 562 may then be retracted further proximally,e.g., via further proximal sliding of actuator sleeve 530, throughtissue and into needle lumens 504 of elongated tubular member 502 tolikewise pull ends 555, 556, 557, 558 of suture 550 through tissue andinto needle lumens 504. Thereafter, arms 542, may be returned to theretracted position and wound closure device 400 may be withdrawn fromthe opening in tissue, leaving suture 550 positioned in a “U”-shapedconfiguration, similarly as detailed above with respect to wound closuredevice 100 (FIGS. 1-9), thus facilitating the tying off of ends 555,556, 557, 558 of suture 550 to close the opening in tissue.

With reference to FIG. 14, another suture configured for use with woundclosure device 500 (FIGS. 11A-11B) is shown as suture 550′. Suture 550′is similar to suture 550 (FIGS. 12-13) in that suture 550′ defines four(4) ends 555′, 556′, 557′, 558′, e.g., via adjoining, knotting,braiding, etc. multiple sutures (or providing two or more separatesutures). However, it is also contemplated that sutures 550 (FIGS.12-13), 550′ be provided with greater or fewer ends, e.g., two (2) endfor use with wound closure devices including two (2) deployable arms.Ends 555′, 556′, 557′, 558′ of suture 550′ each define a loopedconfiguration having a mesh portion 565′, 566′, 567′, 568′ extendingacross the opening defined by the loop. Mesh portions 565′, 566′, 567′,568′ may be formed in any suitable fashion to permit insertion of aneedle therethrough while inhibiting withdrawal of the needle, e.g., bycatching the hooked ends of the needles (see FIG. 13). With additionalreference to FIG. 12, in use, looped ends 555′, 556′, 557′, 558′ ofsuture 550′ may be positioned within annular slots 545 of arms 542,similarly as detailed above with respect to suture 550. However, asmeshed portions 565′, 566′, 567′, 568′ themselves provide the retentionabout needles 562, suture 550′ need not extend through wound closuredevice 500. Rather, each end 555′, 556′, 557′, 558′ of suture 550′ mayextend through the linear slot 547 of a respective arm 542 such that thecentral portion 552′ of suture 550′ is positioned adjacent a distalsurface of end cap 540 and such that each of the ends 555′, 556′, 557′,558′ extends from center portion 552′ to is respective arm 542.

Referring to FIGS. 15A-18B, and initially to FIGS. 15A-15B, anotherwound closure device provide in accordance with the present disclosureis shown generally as wound closure device 600. As detailed below, woundclosure device 600 is configured for use with collar 700, suture grasper800, cartridge 900 (FIGS. 16-18B), and/or any other suitable componentssuch as any of those detailed herein. Wound closure device 600 includesan elongated shaft 610 defining proximal and distal regions 611 a, 611b. A slider 612 is slidably received within the bifurcated proximalregion 611 a of shaft 110 and an end cap 614 is disposed at distalregion 611 b of shaft 610. Shaft 610 further includes a set ofindentations 616 longitudinally arranged on either side thereof (onlyone of which is shown), and a plurality of angled needle lumens 617extending therethrough, the importance of each of which will be detailedbelow.

Wound closure device 600 further includes a sleeve 618 disposed aboutelongated shaft 610 and extending from proximal region 611 a to distalregion 611 b thereof. Sleeve 618 may be formed from first and secondsleeve sections 619 a, 619 b configured to engage one another aboutshaft 610, e.g., via snap-fit engagement or other suitable releasableengagement. Alternatively, sleeve 618 may be integrally formed and/orpermanently disposed about shaft 610 in any suitable fashion. Eachsleeve section 619 a, 619 b is symmetrical relative to the other andincludes a proximal portion that is operably positioned relative toslider 612, and a distal portion that is pivotably engaged to end cap614 of shaft 610, e.g., via a post-recess engagement or other suitablepivotable engagement. Each sleeve section 619 a, 619 b defines adeployable arm 630, 640 proximate its distal portion. Each arm 630, 640includes first and second spaced-apart living hinges 632, 634 and 642,644, respectively, that permit arms 630, 640 to transition between aretracted position (FIG. 15A), corresponding to a proximal position ofslider 612, wherein arms 630, 640 extend along and in generally parallelorientation relative to shaft 610 to facilitate insertion and removal ofwound closure device 600, and a deployed position (FIG. 15B),corresponding to a distal position of slider 612, wherein slider 612urges the proximal portion of sleeve 618 distally relative to the fixeddistal end thereof to flex living hinges 632, 634 and 642, 644 such thatarms 630, 640 extend outwardly from shaft 610 to facilitate retrieval ofa portion of suture retained therein, as will be detailed below.Intermediate segments 636, 646 of arms 630, 640, which extend betweenthe respective living hinges 632, 634 and 642, 644, each define a guideslit 638, 648 configured to guide a needle or other suture graspertowards the portion of suture retained on the respective arm 630, 640,as will be detailed below. Living hinges 632, 634 and 642, 644 may beconfigured such that arms 630, 640 are biased towards the retractedposition, the deployed position, or define a bi-stable configuration.Arms 630, 640 may be configured to retain a portion of suture therein,similarly as detailed with respect to any of the other configurationsherein, or may be configured for use in conjunction with a cartridge 900(FIGS. 16-17) that retains the portion of the suture, as will bedetailed below.

Each sleeve section 619 a, 619 b of sleeve 618 of wound closure device600 further includes first and second elongated openings 622, 624. Whensleeve 618 is engaged about shaft 610, the first opening 622 of eachsleeve section 619 a, 619 b is aligned with one of the angled needlelumens 617 extending through shaft 610 to permit insertion of a needleor other suture grasper through shaft 610 and sleeve 618, tissue, andinto one of the arms 630, 640. The second elongated opening 624 of eachsleeve section 619 a, 619 b exposes indentations 616 of shaft 610 toallow for ratcheting of collar 700 thereabout, as detailed below.

With continued reference to FIGS. 15A and 15B, a collar configured foruse with wound closure device 600 is shown generally as collar 700.Collar 700 includes a body 710 defining a longitudinal bore 712, and anannular rim 720 disposed at the distal end of body 710. Longitudinalbore 712 is configured to permit slidable positioning of collar 700about shaft 610 and sleeve 618. Annular rim 720 defines a tissue-stopsurface such that collar 700 may be slid distally about wound closuredevice 600 to grasp or hold tissue between annular rim 720 and arms 630,640 (when arms 630, 640 are disposed in the deployed position). Annularrim 720 further defines a pair of slots 722, 724 configured to receiveand direct a needle or other suture grasper through shaft 610 and sleeve618, tissue, and into one of the arms 630, 640.

Collar 700 further includes a pair of opposed flexible ratchet tabs 730pivotably disposed on body 710. Teeth 732 of ratchet tabs 730 areconfigured to incrementally engage indentations 616 formed on shaft 610of wound closure device 600 to inhibit collar 700 from moving proximallyas collar 700 is translated distally about shaft 610 and sleeve 618,similarly as detailed above with respect to sleeve 320 of needle andsleeve assembly 300 (FIG. 4).

Suture grasper 800, as shown in FIG. 15B, includes a handle portion 810to facilitate grasping and manipulation of suture grasper 800, and anelongated needle 820 extending distally from handle portion 810. Needle820 is configured for insertion through either slot 722, 724 of collar720, the corresponding opening 622, 624 of sleeve 618, and acorresponding angled needle lumen 617 of shaft 610 such that needle 820is directed through tissue and into the corresponding arm 630, 640 ofsleeve 618. Needle 820 may define a “J” or hook-shaped distal end 822 tofacilitate retrieval of a portion of suture, although other suitableconfigurations are also contemplated.

Referring to FIGS. 16-18B, cartridge 900 configured for use with woundclosure device 600 is shown. Cartridge 900 is configured as apre-loaded, single-use component such that cartridge 900 can beinstalled on wound closure device 600 in preparation for use andreplaced with a new cartridge 900 for subsequent use. Alternatively,cartridge 900 may be reloadable. Cartridge 900 includes a base 910 andfirst and second arms 930, 940 coupled to base via living hinges 932,934. Cartridge 900 may be formed from first and second cartridgeportions 902, 904 configured to releasably engage one another, e.g., viasnap-fit or other suitable releasable engagement, or may be permanentlyformed as a single component.

Base 910 of cartridge 900 defines a generally cylindrical configurationand includes an enclosed end 912 and an open end 914 cooperating todefine a pocket 916. Pocket 916 is configured to receive an intermediateportion 952 of a suture 950 to inhibit tangling or catching of suture950 during use. Base 910 may be releasably seated within shaft 610 ofwound closure device 600 in the distal region thereof, as shown in FIGS.16 and 17, and may be retained therein via friction-fitting or any othersuitable releasable engagement.

Arms 930, 940, as mentioned above, are pivotably coupled to base 910 vialiving hinges 932, 942, and extend from hinges 932, 942 to free ends934, 944. Living hinges 932, 942 permit arms 930, 940 to pivot relativeto base 910 between a retracted position (FIG. 18A) and a deployedposition (FIG. 18B), similar to and in conjunction with arms 630, 640 ofwound closure device 600 (FIGS. 15A-15B). Once base 910 is seated withinshaft 610 of wound closure device 600, arms 930, 940 may be releasablyengaged to respective arms 630, 640 of sleeve 618 of wound closuredevice 600, e.g., via friction-fitting, snap-fitting, or other suitablereleasable engagement. Alternatively or additionally, arms 930, 940 maybe biased towards the deployed position such that arms 930 940 arebiased into contact with arms 630, 640, respectively. Cartridge 900 maybe installed on wound closure device 600 prior to installation of sleeve618 thereabout, or when arms 630, 640 of sleeve 618 are disposed in thedeployed position.

Each arm 930, 940 of cartridge 900 further includes a pair ofspaced-apart retention members 936, 946, respectively, disposed thereon.Retention member 936, 946 may include spring arms, releasable clips, orany other suitable mechanism for releasably retaining a portion ofsuture 950 therein. More specifically, as shown in FIGS. 17 and 18B,retention members 936 of arm 930 retain first end 954 of suture 950suspended therebetween, while retention members 946 of arm 940 retainsecond end 956 of suture 950 suspended therebetween.

Referring to FIGS. 16 and 17 in particular, in use, with arms 630, 640of sleeve 618 of wound closure device 600 disposed in the retractedposition, arms 930, 940 of cartridge 900 are likewise disposed in theretracted position (FIG. 16) to facilitate insertion through an openingin tissue or access device and manipulation into position. Oncepositioned as desired, arms 630, 640 of wound closure device 600 may bedeployed to likewise deploy arms 930, 940 of cartridge 900 (FIG. 17),e.g., as a result of the engagement therebetween and/or the bias of arms930, 940 towards the deployed position. Once arms 930, 940 are deployed,needle 820 of suture grasper assembly 800 may be inserted through slot724 of collar 720 (FIG. 15B), opening 624 (FIG. 15B) of sleeve 618, thecorresponding angled needle lumen 617 (FIG. 15B) of shaft 610, tissue,and slit 638 of intermediate segment 636 of arm 630, such that needle820 is directed between retention members 936 of arm 930, therebyreadily enabling the retrieval of first end 954 of suture 950 using thehooked distal end 822 of needle 820. Needle 820 and first end 954 ofsuture 950 may then be withdrawn proximally through tissue and woundclosure device 600 and a similar process may be effected on the oppositeside to retrieve and withdraw the second end 956 of suture 950proximally through tissue.

With reference to FIGS. 19A-19D, another suture grasper 1000 configuredfor use with wound closure device 600, any of the other wound closuredevices detailed herein, or any suitable wound closure device, is showngenerally as suture grasper 1000. Suture grasper 1000 includes an innershaft 1010, a poly-furcated intermediate shaft 1020 having a pluralityof spring fingers 1022 radially disposed about inner shaft 1010, anouter shaft 1030 disposed about intermediate shaft 1020, and a housingmember 1040 disposed about outer shaft 1030. Inner shaft 1010 andhousing member 1040 are fixed relative to one another, while bothintermediate shaft 1020 and outer shaft 1030 are slidable relative toinner shaft 1010 and housing member 1040 and relative to one another.

Inner shaft 1010 defines a conical distal end 1012 configured tofacilitate penetration of tissue, although other configurations are alsocontemplated. Spring fingers 1022 of intermediate shaft 1020 are biasedtowards a spread position, wherein spring fingers 1022 extend radiallyoutwardly from inner shaft 1010 and one another (FIG. 19B). In a fullycompressed or retracted position, spring fingers 1022 cooperate todefine a generally tubular intermediate shaft 1020 having an innerdiameter similar to the outer diameter of inner shaft 1010 (FIG. 19A).Outer shaft 1030 defines an inner diameter larger than the outerdiameters of inner shaft 1010 and intermediate shaft 1020 butsufficiently small so as to compress spring fingers 1022 towards or totheir fully compressed position when disposed about spring fingers 1022.Housing member 1040 may be configured to facilitate grasping andmanipulation of suture grasper 1000 and may further include first andsecond actuators (not shown) for actuating intermediate shaft 1020 andouter shaft 1030, respectively.

Suture grasper 1000 is configured to transition among four (4)configurations: a penetration configuration, as shown in FIG. 19A,wherein suture grasper 100 defines a low-profile configuration withconical distal end 1012 of inner shaft 1010 exposed to facilitatepenetration of tissue; an open configuration, as shown in FIG. 19B,wherein intermediate shaft 1020 is maintained in position while outershaft 1030 is moved proximally such that spring fingers 1022 arepermitted to extend radially outwardly, under bias, from inner shaft1010; an extended configuration, as shown in FIG. 19C, wherein bothintermediate shaft 1020 and outer shaft 1030 are moved distally suchthat spring fingers 1022 extend to distal end 1012 of inner shaft 1010;and a grasping configuration, as shown in FIG. 19D, wherein outer shaft1030 is fully extended to the distal end 1012 of inner shaft 1010 tocompress spring fingers 1022 towards or to their fully compressedposition about inner shaft 1010. The use of suture grasper 1000 isdetailed below.

Spring fingers 1022 of suture grasper 1000 may further includeinwardly-extending barb features (not explicitly shown), or othersuitable retention features (such as any of those detailed herein or anyother suitable retention feature) to facilitate retaining a portion ofsuture between spring fingers 1022 and inner shaft 1010. In suchembodiments, inner shaft 1010 may include complementary recesses (notexplicitly shown) defined therein that are configured to receive thebarb features of spring fingers 1022 in mating engagement to retain thesuture therebetween.

With reference to FIGS. 20A-20D, the use of suture grasper 1000 inconjunction with wound closure device 600 and cartridge 900 isdescribed, although suture grasper 1000 may alternatively be used aloneor with any other wound closure device(s). Initially, wound closuredevice 600 is inserted through an opening in tissue or access device,manipulated into position, and arms 630, 640 (FIG. 15B) are deployed tolikewise deploy arms 930, 940 of cartridge 900 (FIG. 15B).

Next, as shown in FIG. 20A, with suture grasper 1000 disposed in thepenetration configuration, suture grasper 1000 is advanced through woundclosure device 600 and tissue, lead by conical distal end 1012 of innershaft 1010, until distal end 1012 of inner shaft 1010 is positionedbetween the retention members 946 of the corresponding arm 940 ofcartridge 900 adjacent the end 956 of suture 950 retained thereon. Oncethis position has been achieved, as shown in FIG. 20B, suture grasper1000 may be transitioned to the open configuration, wherein springfingers 1022 extend radially outwardly, under bias, from inner shaft1010, and then to the extended configuration, as shown in FIG. 20,wherein spring fingers 1022 extend to distal end 1012 of inner shaft1010 such that the end 956 of suture 950 is disposed between at leastone of the spring fingers 1022 and inner shaft 1010.

Thereafter, suture grasper 1000 may be transitioned to the graspingconfiguration, as shown in FIG. 20D, wherein outer shaft 1030 compressesspring fingers 1022 about inner shaft 1010 to retain the end 956 ofsuture 950 therebetween. Suture grasper 1000, with end 956 of suture 950retained thereon, may then be withdrawn proximally through tissue andwound closure device 600 and a similar process may be effected on theopposite side to retrieve and withdraw the other end of suture 950proximally through tissue.

Referring to FIGS. 21-22, another wound closure device provided inaccordance with the present disclosure is shown generally as woundclosure device 1100. Wound closure device 1100 includes an elongatedshaft 1110 defining proximal and distal regions 1111 a, 1111 b,respectively, a plunger 1120 slidably received within shaft 1110 andextending longitudinally through shaft 1110, and a pair of selectivelydeployable arms 1130, 1140 operably coupled to shaft 1110 and plunger1120 at respective distal regions 1111 b, 1121 of shaft 1110 and plunger1120.

Shaft 1110 is configured for insertion through a wound or other openingin tissue and defines a longitudinal bore 1112 extending therethroughthat is configured to slidably receive plunger 1120. First and secondarms 1130, 1140 are coupled to distal region 111 b of shaft 1110 onopposite sides thereof via living hinges 1132, 1142. Shaft 1110 furtherdefines a plurality of angled needle lumens 1114 configured to direct aneedle inserted therethrough to a corresponding arm 1130, 1140. Althoughonly two needle lumens 1114 are shown, it is contemplated that aplurality of pairs of angled needle lumens 1114 be provided at differentlongitudinal positions along shaft 1110 for use with various tissuethicknesses and/or tissue layer structures.

Plunger 1120 includes a distal region 1121 that extends distally beyonddistal region 111 b of shaft 1110. The proximal region (not shown) ofplunger 1120 may include an actuator (not shown) for selectivelytranslating plunger 1120 through and relative to bore 1112 of shaft1110, similarly as detailed above with respect to wound closure device100 (FIG. 1). First and second arms 1130, 1140 are coupled to distalregion 1121 of plunger 1120 via a pivot pin 1122, although separatepivot pins and/or other pivotable engagement structures, e.g., livinghinges, are also contemplated.

Each arm 1130, 1140 defines first and second segments 1134, 1136 and1144, 1146, respectively, interconnected via a living hinge 1138, 1148,respectively. First segments 1134, 1144 are coupled to shaft 1110 vialiving hinges 1132, 1142, respectively, and define openings 1139, 1149configured to retain, suspend, seat, receive, and/or otherwise providefor the depositing or retrieval of portion of suture. Variousembodiments of such are detailed below. Second segments 1136, 1146 arecoupled to distal region 1121 of plunger 1120 via pivot pin 1122.

As a result of the above-detailed configuration of arms 1130, 1140 withrespect to shaft 1110 and plunger 1120, plunger 1120 may be translatedthrough and relative to shaft 1110 between a distal position and aproximal position. The distal position corresponds to the retractedposition of arms 1130, 1140 (FIG. 21), wherein arms 1130, 1140 aregenerally disposed within the outer radial dimension of shaft 1110 withthe respective segments 1134, 1136 and 1144, 1146 thereof disposed inlinear orientation. The proximal position corresponds to the deployedposition of arms 1130, 1140 (FIG. 22), wherein arms 1130, 1140 arepivoted about living hinges 1132, 1142 and pivot pin 1122 and whereinsegments 1134, 1136 and 1144, 1146 are pivoted relative to one anotherabout living hinges 1138, 1148, respectively, such that segments 1134,1144 are positionable adjacent an internal surface of tissue and suchthat openings 1139, 1149 are disposed in alignment with angled needlelumens 1114. Living hinges 1132, 1142, 1138, 1148 and pivot pin 1122 maybe configured to bias arms 1130, 1140 towards the deployed position, theretracted position, or may define a bi-stable configuration. The use ofwound closure device 1100 may be similar to that of wound closure device100 (FIG. 1), detailed above.

Turning now to FIG. 23, another wound closure device provided inaccordance with the present disclosure is shown generally as woundclosure device 1200. Wound closure device 1200 is similar to woundclosure device 1100 (FIGS. 21-22) except that, rather than living hingescoupling first and second arms 1230, 1240 to shaft 1210, pivot pins1232, 1242 are provided and, rather than living hinges coupling thesegments 1234, 1236 and 1244, 1246 of arms 1230, 1240 to one another,pivot pins 1238, 1248, respectively, are provided. Wound closure device1200 may otherwise be configured similar to wound closure device 1100(FIGS. 21-22) in both structure and operation. Wound closure device 1200and/or wound closure device 1100 (FIGS. 21-22), may further include aplurality of teeth 1226 longitudinally disposed along a portion thereofon either side thereof (see FIG. 24).

With reference to FIG. 24, a collar configured for use with woundclosure device 1200 is shown generally as collar 1300. Collar 1300 issimilar to collar 700 (FIGS. 15A-15B) any generally includes a body 1310defining a longitudinal bore 1312, an annular rim 1320 disposed at thedistal end of body 1310, and a pair of opposed flexible ratchet tabs1330 pivotably disposed on body 1310. Collar 1300 is slidablypositionable about shaft 1210 of wound closure device 1200. Annular rim1320 defines a distally-facing tissue-stop surface such that collar 1300may be slid distally about wound closure device 1300 to grasp tissuebetween annular rim 1320 and arms 1230, 1240. Each ratchet tab 1330includes a tooth 1332 extending into longitudinal bore 1312 andconfigured for engagement between any adjacent pair of teeth 1226defined on shaft 1210 to lock collar 1300 in a desired position todefine a suitable tissue gap “G” between annular rim 1320 and arms 1230,1240, depending on the thickness of tissue, structure of tissue layers,etc. Grasping or retaining tissue between annular rim 1320 and arms1230, 1240 also serves to stabilize wound closure device 1200 within theopening in tissue. In order to release or unlock ratchet tabs 1330,spring legs 1334 of ratchet tabs 1330 are flexed inwardly such thatteeth 1332 are pivoted out of engagement between teeth 1226 of shaft1210, thus permitting collar 1300 to be returned proximally. Uponrelease of spring legs 1334, teeth 1332 are pivoted, under bias ofspring legs 1334, back into engagement with teeth 1226 of shaft 1210,e.g., towards the locked position.

FIGS. 25A-25B show another collar 1400 provided in accordance with thepresent disclosure and configured for use with wound closure device 1200(or other suitable device) for grasping or maintaining tissue betweencollar 1400 and arms 1230, 1240 of wound closure device 1200. Collar1400 generally includes a body 1410 defining a longitudinal bore 1412,and a rotatable lock member 1430 pivotably disposed on body 1410. Collar1400 is slidably positionable about shaft 1210 of wound closure device1200 and may further include an annular rim (not shown) similar toannular rim 1320 of collar 1300 (FIG. 24). Body 1410 of collar 1400 maydefine a “C”-shaped configuration, as shown in FIG. 25B, or may define afull annular configuration.

Rotatable lock member 1430 is pivotably coupled to body 1410 and has aprotruding portion 1432 rotatable between an unlocked position (FIG.25A), where protruding portion 1432 is displaced from bore 1412 topermit collar 1400 to slide about shaft 1210, and a locked position,wherein protruding portion 1432 extends into bore 1412 to frictionallyengage shaft 1210, thereby locking lock collar 1400 in position aboutshaft 1210 between the internal surface of body 1410 that defines bore1412 and protruding portion 1432 of lock member 1430. Thus, once collar1400 is positioned to define the desired gap distance between collar1400 and arms 1230, 1240, lock member 1430 may be rotated from theunlocked position to the locked position to lock collar 1400 inposition.

Referring to FIGS. 26-27, in conjunction with FIG. 22, another suturepasser 1500 configured for use with wound closure device 1100 (or anyother suitable wound closure device) is shown generally as suture passer1500. Suture passer 1500 generally includes a handle portion 1510, anelongated body 1520 extending distally from handle portion 1510, and aplunger 1530. Plunger 1530 includes an actuator 1532 extendingproximally from handle portion 1510 and an actuation shaft 1534 slidablydisposed within body 1520.

With particular reference to FIG. 27, handle portion 1510 isergonomically configured to facilitate grasping of suture passer 1500,and defines a longitudinal passageway 1512 extending therethrough.Longitudinal passageway 1512 defines a minimum width suitable toslidably receive actuation shaft 1534 of plunger 1530 and includes afirst chamber 1514 having a larger width than the minimum width, and asecond chamber 1516 positioned distally adjacent first chamber 1514 anddefining a width equal to or larger than the first expanded portion 1514in a first dimension and a width smaller than the first expanded portion1514 in a second dimension (the second dimension is shown in FIG. 27).As such, first and second shoulders 1515, 1517 are defined between firstand second chambers 1514, 1516, and between passageway 1512 and secondchamber 1516, respectively.

Elongated body 1520 is fixedly engaged to and extends distally fromhandle portion 1510. Elongated body 1520 defines a longitudinal lumen1522 in communication with longitudinal passageway 1512, thus permittingactuation shaft 1534 of plunger 1530 to extend through handle portion1510 and into elongated body 1520. Elongated body 1520 further definesan open distal tip 1524 that may be pointed or otherwise configured tofacilitate penetration through tissue, and a window 1526 defined withinthe side wall of elongated body 1520 near the distal region thereof.

Suture 1550 includes first and second ends 1552, 1554, each having aretention member 1553, 1555 secured thereto. Retention members 1553,1555 and, thus, first and second ends 1552, 1554 of suture 1550 areinitially disposed within longitudinal lumen 1522 of elongated body 1520adjacent window 1524. Retention members 1553, 1555 are dimensioned toenable passage through openings 1139, 1149 of arms 1130, 1140 (see FIG.22) in only one or a few particular orientations, thus inhibitingaccidental or un-intended withdrawal of retention members 1553, 1555through openings 1139, 1149 of arms 1130, 1140 (FIG. 22).

Plunger 1530, as mentioned above, includes an actuator 1532 extendingproximally from handle portion 1510 and an actuation shaft 1534 slidablydisposed within body 1520. Actuation shaft 1534 includes a biasingmember 1536 disposed thereabout and a selector 1538 engaged aboutactuation shaft 1534 proximally of biasing member 1536. Biasing member1536 is longitudinally maintained between selector 1538 and secondshoulder 1517 defined within handle portion 1510. Selector 1538 definesa rectangular or other non-radially-symmetrical configuration shapedcomplementary to the first and second dimensions of second chamber 1516such that, in a first orientation of selector 1538 relative tolongitudinal passageway 1512 (FIG. 27), selector 1538 is inhibited fromtranslating from first chamber 1514 of longitudinal passageway intosecond chamber 1516 of longitudinal passageway 1512, and such that, in asecond orientation of selector 1538 relative to longitudinal passageway1512, selector 1538 is permitted to translate distally from firstchamber 1514 into second chamber 1516. Thus, in the first orientation,plunger 1530 is translatable from a proximal position to an intermediateposition, wherein selector 1538 abuts first shoulder 1515, while, in thesecond orientation, plunger 1530 is translatable distally from theproximal position to a distal position, wherein selector 1538 abutssecond shoulder 1517. Biasing member 1536 biases plunger 1530 towardsthe proximal position.

Referring again to FIGS. 22, 26, and 27, in use, with plunger 1530disposed in the proximal position (FIG. 27), elongated body 1520 ofsuture passer 1500 may be inserted through one of the needle lumens 1114of shaft 1110, through tissue, and through the opening 1139 definedwithin the corresponding arm 1130. Thereafter, plunger 1530, in thefirst orientation, may be translated distally from the proximal positionto the intermediate position such the distal end of actuation shaft 1534contacts retention member 1553 which, in turn, contacts retention member1555 and urges retention member 1555 distally through open distal tip1524 of elongated body 1520. Alternatively, suture passer 1500 may beconfigured to eject retention members 1553, 1555 through window 1526.Plunger 1530 may then be withdrawn proximally from arm 1130, tissue, andshaft 1110. As noted above, the dimensions of retention member 1555inhibit proximal translation of retention member 1555 through arm 1130,thus maintaining second end 1554 of suture 1550 in engagement with arm1130.

Next, elongated body 1520 of suture passer 1500 may be inserted throughthe other needle lumen 1114 of shaft 1110, through tissue, and throughthe opening 1149 defined within the corresponding arm 1140. Thereafter,plunger 1530 may be transitioned to the second orientation, e.g., viarotating plunger 1530 relative to body 1520, such that plunger 1530 maybe translated distally from the proximal position to the distalposition. Translation of plunger 1530 to the distal position allows thedistal end of actuation shaft 1534 to contact and eject the retentionmember 1553 through open distal tip 1524 of elongated body 1520. Plunger1530 may then be withdrawn proximally from arm 1140, tissue, and shaft1110, leaving retention member 1553 and first end 1553 of suture 1550retained in engagement with arm 1140.

Ultimately, wound closure device 1200 may be returned to the retractedposition and withdrawn from the opening in tissue, leaving ends 1552,1554 of suture 1550 to be tied off in a configuration similar to thatshown in FIG. 9.

Turning to FIGS. 28-29B, another suture passer 1600 configured for usewith a wound closure device 1200′ similar to wound closure device 1200(FIG. 23) is shown, although suture passer 1600 may alternatively beconfigured for use with any other suitable wound closure device. Woundclosure device 1200′, as shown in FIG. 28, is similar to wound closuredevice 1200 (FIG. 23) but differs mainly in that wound closure device1200′ only includes a single arm 1230′. Wound closure device 1200′further differs in that second segment 1236′ of arm 1230′ includes aretention member dock 1237′ and plunger 1220′ defines a recess 1223′configured to receive retention member dock 1237′ when arm 1230′ isdisposed in the retracted position. Suture passer 1600 and wound closuredevice 1200′ are configured for use with a suture 1650 including aretention member 1653 disposed at an end 1652 thereof. Retention member1653 includes one or more resilient engagement legs 1655 and defines aninner pocket 1657.

Referring to FIGS. 29A-29B, suture passer 1600 generally includes ahandle portion 1610, an elongated body 1620 extending distally fromhandle portion 1610, and a plunger 1630. Plunger 1630 includes anactuator 1632 extending proximally from handle portion 1610 and anactuation shaft 1634 slidably disposed within body 1620.

Handle portion 1610 is ergonomically configured to facilitate graspingof suture passer 1600 and defines a longitudinal passageway (not shown)configured to receive actuation shaft 1634. Elongated body 1620 isfixedly engaged to and extends distally from handle portion 1610.Elongated body 1620 defines a longitudinal lumen 1622 in communicationwith the passageway (not shown) of handle portion 1610 at its proximalend and an open distal end. Elongated body 1620 further includes adistal portion 1624 defining one or more engagement recesses 1626.Distal portion 1624 is configured to releasably retain a retentionmember 1653 of suture 1650, as detailed below.

A biasing member (not shown) may be provided for biasing plunger 1630towards a proximal position, wherein actuation shaft 1634 does notextend distally from elongated body 1620. Plunger 1630 is selectivelytranslatable relative to handle portion 1610 and elongated body 1620between this proximal position (FIG. 29A) and a distal position (FIG.29B), wherein a portion of actuation shaft 1634 extends distally fromthe distal end of elongated body 1620.

With reference again to FIGS. 28-29B, in use, retention member 1653 isinitially engaged about elongated body 1620 such that distal portion1624 of elongated body 1620 is received within inner pocket 1657 ofretention member 1653 and such that the one or more resilient engagementlegs 1655 of retention member 1653 are engaged within the one or moreengagement recesses 1626, as shown in FIG. 29A.

With retention member 1653 engaged about distal portion 1624 ofelongated body 1620, elongated body 1620 of suture passer 1600 may beinserted through the needle lumen 1214′ of shaft 1210′ of wound closuredevice 1200′, through tissue, and through the opening 1239′ definedwithin first segment 1234′ of arm 1230′. Elongated body 1620 is advancedthrough arm 1230′ until retention member 1653 is received within dock1237′, e.g., via friction-fitting or other suitable releasableengagement. Thereafter, plunger 1630 may be translated to the distalposition such that actuation shaft 1634 extends distally from elongatedbody 1620 and into contact with retention member 1653 under sufficienturging to flex resilient engagement legs 1655 outwardly and out ofengagement from within engagement recesses 1626 to disengage retentionmember 1653 from about distal portion 1624 of elongated body 1620. Onceretention member 1653 has been disengaged, suture passer 1600 may bewithdrawn, leaving retention member 1653 engaged within dock 1637′ and aportion of suture 1650 extending through tissue.

Wound closure device 1200′ may then be rotated relative to the openingin tissue such that arm 1230′ is positioned on an opposite side of theopening in tissue. Thereafter, elongated body 1620 of suture passer 1600may be once again inserted through the needle lumen 1214′ of shaft 1210′of wound closure device 1200′, through tissue, and through the opening1239′ defined within first segment 1234′ of arm 1230′. Elongated body1620 is advanced through arm 1230′ with sufficient urging such thatdistal portion 1624 of elongated body 1620 is urged into inner pocket1657 of retention member 1653 and such that the one or more resilientengagement legs 1655 of retention member 1653 are initially flexedoutwardly and then resiliently returned into engagement withinengagement recesses 1626. Thus, with retention member 1653 once againengaged to suture passer 1600, suture passer 1600 may be withdrawn topull retention member 1653 and a portion of suture 1650 proximallythrough tissue on the other side of the opening, ultimately allowingsuture 1650 to be tied off in a configuration similar to that shown inFIG. 9.

As an alternative to defining engagement recesses 1626, or in additionthereto, distal portion 1624 of elongated body 1620 of suture passer1600 may define a plurality of proximally-extending fingers (not shown).In such a configuration, the proximally-extending fingers are flexedinwardly to permit passage of distal portion 1624 of elongated body 1620into the interior of the retention member, e.g., retention member 1653.However, once disposed therein, withdrawal of distal portion 1624 ofelongated body 1620 is inhibited via engagement of theproximally-extending fingers with the interior surface of the retentionmember. Other suitable configurations are also contemplated.

Referring to FIGS. 30-32, another wound closure device provided inaccordance with the present disclosure is shown generally as woundclosure device 1200″. Wound closure device 1200″ is configured for usewith a suture grasper 1270 (FIG. 32) and a suture 1290, although any ofthese components may alternatively or additionally be used in accordancewith any of the other components detailed herein.

Suture 1290 defines first and second ends 1292 and an intermediateportion 1294. A retention member 1295 releasably mounted on a cartridge1298 is defined at each end 1292 of suture 1290. Retention members 1295are formed via weaving, knitting, meshing, stitching, or otherwiseintertwining the end 1292 of suture 1290 (alone or with other materials)to define a suture web 1296 defining a plurality of openings 1297.Retention members 1295 may be releasably retained on cartridge 1298 inany suitable fashion, e.g., via adhesives, releasable clips, etc.

Cartridges 1298 each includes a base 1299 a and legs 1299 b engaged tobase 1299 a on either end thereof. Legs 1299 b are configured forreleasable receipt within engagement slots 1284 defined within secondsegments 1282 of arms 1280 of wound closure device 1200″, as will bedetailed below. Bases 1299 a are configured to retain retention members1295 thereon, e.g., via adhesives, releasable clips, etc., and furtherdefine openings 1299 c within the retention-member supporting surfacethereof, the importance of which will be detailed below.

Wound closure device 1200″ is similar to wound closure device 1200 (FIG.23) and further includes a slot 1284 defined within the second segment1282 of each arm 1280. Each slot 1284 is configured to releasablyreceive a retention member 1295 retaining an end 1292 of a suture 1290.More specifically, slots 1284 are shaped complementary to legs 1299 b,e.g., defining “T”-shaped configurations, such that legs 1299 b may beengaged with slots 1284 via transversely sliding cartridges 1298relative to arms 1280, as shown in FIG. 31. In preparation for use, withwound closure device 1200 disposed in the deployed configuration (FIG.30), cartridges 1298 may be engaged within arms 1280 as noted above andsuch that intermediate portion 1294 of suture extends about the distalend of wound closure device 1200″. Thereafter, wound closure device1200″ may be moved to the retracted condition to facilitate insertionthrough the opening in tissue.

Continuing with reference to FIGS. 30-32, in use, once wound closuredevice 1200″ has been inserted through the opening in tissue andtransitioned to the deployed condition, suture grasper 1270, lead byhooked distal end 1272 may be inserted through wound closure device1200″, tissue, and into one of the arms 1280. More specifically, hookeddistal end 1272 of suture grasper 1270 is urged into one of the arms1280 and through one of openings 1297 in web 1296 of retention member1295 and opening 1299 c in base 1299 a of cartridge 1298. Once insertedto this position, suture grasper 1270 may be retracted such that thehooked distal end 1272 hooks or grasps at least a portion of theretention member 1295 of suture 1290, disengages the retention member1295 from cartridge 1298 and retracts the retention member 1295 ofsuture 1290 proximally through tissue. The process may then be repeatedwith respect to the other arm member 1280, ultimately allowing suture1290 to be tied off in a configuration similar to that shown in FIG. 9.For subsequent use, the spent cartridges 1298 are removed from arms 1280and wound closure device 1200″ is loaded with a new suture 1290,similarly as detailed above.

With reference to FIG. 33, another wound closure device 1700 similar towound closure device 1200′ (FIG. 28) is shown. Wound closure device 1700differs from wound closure device 1200′ (FIG. 28) mainly in that, ratherthan providing a retention dock, opening 1739 located on first segment1734 of arm 1730 is configured to releasably retain a retention member1753 disposed at an end of a suture 1750, thus allowing the retentionmember 1753 and, thus, the end of suture 1750 to be retrieved via asuitable suture grasper and withdrawn proximally through tissue,similarly as detailed above with respect to previous embodiments.Various embodiments of retention members and corresponding suturegraspers suitable for this purpose are detailed below with reference toFIGS. 34-36.

Referring to FIG. 34, a suture grasper 1800 and corresponding retentionmember 1853 configured for use therewith are shown. Retention member1853 defines a flexible ring, e.g., formed from an elastomeric material,having an initial at-rest diameter “d.” Retention member 1853 mayfurther defines an aperture through the outer portion thereof that isconfigured to receive an end of a suture 1850, although suture 1850 mayalternatively be looped about retention member 1853, e.g., through thecentral opening thereof. Retention member 1853 is configured forreleasable receipt within opening 1739 of arm 1730 (FIG. 33).

Suture grasper 1800 includes an outer shaft 1810 and a needle 1820extending distally from outer shaft 1810. Needle 1820 defines a conicaldistal end 1822 configured to facilitate penetration through tissue,although other configurations are also contemplated. Needle 1820 furtherdefines one or more pairs of opposed barbs 1824. Each pair of barbs 1824is spaced-apart and curved or angled proximally. The maximum diameter“D” of needle 1820, as defined by the free ends of each pair of barbs1824, is larger than the diameter “d” of retention member 1853. Thus,upon insertion of needle 1820 into opening 1739 of arm 1730 (FIG. 33),retention member 1853 is flexed outwardly to permit passage of distalend 1822 of needle 1820 therethrough. Once distal end 1822 of needle1820 has passed through retention member 1853, the proximally-facingbarbs 1824 inhibit disengagement of retention member 1853 from aboutdistal end 1822 of needle 1820. Accordingly, needle 1820 and the end ofsuture 1850 may together be withdrawn through tissue.

FIG. 35 shows another suture grasper 1900 and corresponding retentionmember 1953 configured for use therewith. Suture grasper 1900 andretention member 1953 are similar to suture grasper 1800 and retentionmember 1853 (FIG. 34), respectively. Retention member 1953 differs fromretention member 1853 (FIG. 34) mainly in that the retention member 1953defines a flexible ring having an irregular central opening 1955. Morespecifically, portions 1954 of retention member 1953 protrude inwardlyinto central opening 1955 to reduce central opening 1955 at variouspositions and/or cut-outs 1956 are defined within retention member 1953to enlarge central opening 1955 at various positions.

Suture grasper 1900, similar to suture grasper 1800 (FIG. 34) includesan outer shaft 1910 and a needle 1920 extending distally from outershaft 1910. Needle 1920 defines a conical distal end 1922 configured tofacilitate penetration through tissue, although other configurations arealso contemplated. Conical distal end 1922 of needle 1920 and body 1924of needle 1920 cooperate to define a proximally-facing shoulder 1926.Similar to barbs 1824 of suture grasper 1800 (FIG. 34), conical distalend 1922 permits insertion of needle 1920 through retention member 1953,while shoulder 1926 and the irregular central opening 1955 of retentionmember 1953 cooperate to inhibit withdrawal of needle 1920 fromretention member 1953. Accordingly, once engaged, needle 1920 and theend of suture 1950 may together be withdrawn through tissue.

Turning to FIG. 36, another suture grasper 2000 and correspondingretention member 2053 configured for use therewith are shown. Retentionmember 2053 is formed via weaving, knitting, meshing, stitching, orotherwise intertwining the end of suture 2050 (alone or with othermaterials) to define a suture web 2054 defining a plurality of openings2055.

Suture grasper 2000 is similar to suture grasper 1800 (FIG. 34) butdiffers mainly in that conical distal tip 2022 of needle 2020 of suturegrasper 2000 includes a plurality of radially-spaced barbs 2024 disposedthereabout. Suture grasper 2000 further differs in that needle 2020 isslidable relative to outer shaft 2010 and is biased proximally relativeto outer shaft 2010 via a biasing member 2030. In the proximal position(not shown), distal tip 2022 of needle 2020 is at least partiallydisposed within outer shaft 2010.

In use, needle 2020 is moved to a distal position (FIG. 36) against thebias of biasing member 2030 such that conical distal end 2022 of needle2020 extends distally from outer shaft 2010. Thereafter, needle 2020 isurged distally relative to retention member 2053 such that conicaldistal end 2022 of needle 2020 is urged into contact with suture web2054 under sufficient urging to enlarge and pass distally through one ofthe web openings 2055 defined by the portions of suture forming sutureweb 2054. Conical distal end 2022 of needle 2020 facilitates this distalpassing through one of the web openings 2055. However, once barbs 2024have been advanced distally through the web opening 2055 to a positiondistal of suture web 2054, radially-spaced barbs 2024 inhibit proximalwithdrawal of needle 2020 from web opening 2055. Rather, upon proximaltranslation of needle 202 relative to suture web 2054, barbs 2024 areengaged with the portions of suture forming suture web 2054. As such,when needle 2020 is moved back to the proximal position, e.g., underbias, retention member 2053 is likewise retracted proximally into outershaft 2010 such that needle 2020 and the end of suture 2050 may togetherbe withdrawn through tissue.

With reference to FIGS. 37-41, another wound closure device 2100provided in accordance with the present disclosure is shown generally aswound closure device 2100. Wound closure device 2100 is configured foruse with a sleeve 2200 and a suture grasper 2300, as will be detailedbelow.

Wound closure device 2100 includes an elongated shaft 2110, a proximalarm 2120 pivotably coupled to elongated shaft 2110 at the proximal end2111 a of elongated shaft 2110, and a distal arm 2130 pivotably coupledto elongated shaft 2110 at the distal end 2111 b of elongated shaft2110. Proximal and distal arms 2120, 2130 are coupled to one another viaone or more linkages 2140, e.g., cables, such that pivoting of proximalarm 2120 relative to elongated shaft 2110 in a first direction effectscorresponding pivoting of distal arm 2130 relative to elongated shaft2110 in an opposite direction (see FIGS. 38 and 39). Proximal arm 2120remains external of tissue during use, thus functioning as an actuatorthat enables the user to selectively pivot distal arm 2130, which isinternally-disposed, to a desired position. Distal arm 2130 includesfirst and second opposed surfaces 2132, 2134, respectively. As can beappreciated, depending on the direction of pivoting of distal arm 2130,first surface 2132 may be proximally-facing (as shown in FIGS. 38, 39,and 41), or second surface 2134 may be proximally-facing (when distalarm 2130 is pivoted in the opposite direction). Elongated shaft 2110 isconfigured for insertion through the opening in tissue.

With particular reference to FIG. 41, wound closure device 2100 isfurther configured to retain a suture 2400 therein. More specifically,suture 2400 includes an body portion 2410 that is routed throughelongated shaft 2110, and end portions 2420 having first and secondsegments 2422, 2424 operably disposed about first and second surfaces2132, 2134, respectively, of distal arm 2130, and releasably retainedthereon in any suitable manner, e.g., via adhesives, tacking, etc.

Referring again to FIGS. 37-41, sleeve 2200 is similar to sleeve 320 ofneedle and sleeve assembly 300 (FIG. 4) and generally includes a body2220 having a proximal collar 2222 and a bifurcated distal end 2224defining first and second fingers 2226, 2228. A central passageway 2230is configured to slidably receive shaft 2110 of wound closure device2100 and extends longitudinally through body 2220 of sleeve 2100. Firstand second curved needle lumens 2240, 2250 are defined through body 2220on either side of central passageway 2230. The curvature of needlelumens 2240, 2250 directs a needle inserted therethrough towards theportion of suture to be retrieved, as will be detailed below.

With reference to FIG. 40, suture grasper 2300 includes a handle portion2310 and a needle 2320 extending distally from handle portion 2310.Needle 2320 defines a pre-curved configuration having a radius ofcurvature similar to that of needle lumens 2240, 2250 of sleeve 2200(FIG. 41) and/or defines a flexible configuration to facilitateinsertion of needle 2320 through either needle lumen 2240, 2250 (FIG.41). Needle 2320 further includes a hooked or “J”-shaped distal end2322.

With continued reference to FIGS. 37-41, the use and operation of woundclosure device 2100 is similar to that of wound closure device 100(FIG. 1) with respect to use in conjunction with an access device, e.g.,surgical access device 200 (FIG. 3), and sleeve 2200. More specifically,referring initially to FIG. 37, once wound closure device 2100 has beeninserted through the opening in tissue in a linear position (and theaccess device removed), sleeve 2200 may be slid distally over proximalarm 2120 such that sleeve 2200 is disposed about elongated shaft 2110.Thereafter, as shown in FIG. 38, proximal arm 2120 may be pivotedrelative to elongated shaft 2110 to pivot distal arm 2130 such thatsecond surface 2134 of distal arm 2130 and second segment 2424 of suture2400 (FIG. 41) are positioned proximally-adjacent and facing an internalsurface of tissue. Sleeve 2200 may subsequently be approximated relativeto tissue to grasp or retain tissue between finger 2228 of sleeve 2200and distal arm 2130 of wound closure device 2100.

Referring to FIGS. 39 and 41, once the above-noted position has beenachieved, needle 2320 of suture grasper 2300, lead by hooked distal end2322 of needle 2320, is inserted through curved needle lumen 2250 andthrough tissue such that hooked distal end 2322 of needle 2320 isdirected towards second surface 2134 of distal arm 2130. Suture grasper2300 may then be manipulated to hook second segment 2424 of suture 2400and withdrawn proximally to pull second segment 2424 proximally throughtissue. Thereafter, proximal arm 2120 may be pivoted relative toelongated shaft 2120 in the opposite direction to pivot distal arm 2130such that first surface 2132 of distal arm 2130 and first segment 2422of suture 2400 (FIG. 41) are positioned proximally-adjacent and facingan internal surface of tissue, on the opposite side of the opening intissue. Needle 2320 may then be inserted through curved needle lumen2240 and through tissue to retrieve and withdrawn first segment 2422 ofsuture 2400 proximally through tissue, ultimately such that suture 2400may be tied off in a configuration similar to that shown in FIG. 9.

With reference to FIGS. 42-43B, another wound closure device 2500provided in accordance with the present disclosure is shown generally aswound closure device 2500. Wound closure device 2500 is configured foruse with sleeve 2200 and suture grasper 2300, similarly as detailedabove with respect to wound closure device 2100 (FIGS. 37-39).Accordingly, only the differences between wound closure device 2500 andwound closure device 2100 (FIGS. 37-39) are detailed below.

Wound closure device 2500 includes an outer shaft 2510, and a plunger2520 slidably disposed within outer shaft 2510. Plunger 2520 includesfirst and second spring arms 2530, 2540 extending from the distal endthereof. Spring arms 2530, 2540 are biased towards anoutwardly-extending position, wherein spring arms 2530, 2540 extendradially outwardly from plunger 2520 in opposite directions relative toone another, as shown in FIG. 43B. Plunger 2520 is slidable relative toouter shaft 2510 between a retracted condition (FIG. 43A), whereinspring arms 2530, 2540 are disposed within outer shaft 2510 in closeproximity to one another, and a deployed condition (FIG. 43B), whereinspring arms 2530, 2540 extend distally from outer shaft 2510, thusallowing spring arms 2530, 2540 to achieve the outwardly-extendingposition.

A suture 2600 configured for use with wound closure device 2500 includesan body 2610 routed through outer shaft 2510, a first end 2620releasably looped about the free end of first spring arm 2530, and asecond end 2630 releasably looped about the free end of second springarm 2540. Thus, with plunger 2520 disposed in the deployed position,suture grasper 2300 may be utilized to sequentially retrieve first andsecond ends 2620, 2630 of suture, such that suture 2600 may ultimatelybe tied off in a configuration similar to that shown in FIG. 9.

Turning to FIGS. 44A and 44B, as an alternative to releasably loopingfirst and second ends 2620, 2630 of suture 2600 about the free ends ofspring arms 2530, 2540 (FIG. 43B), respectively, another embodiment ofspring arms 2550 (only one of which is shown) may be provided, similarto spring arms 2530, 2540 (FIG. 43B). Each spring arm 2550 includesbifurcated distal end 2552 having first and second spaced-apart fingers2554, 2556 and defining an opening 2558 between fingers 2554, 2556. Atleast one of fingers 2554, 2556 includes a protrusion 2559 disposed atthe free end thereof to substantially enclose opening 2558, as shown inFIG. 44A. Each spring arm 2550 is configured to receive a knotted end2710 of a suture 2700 with the knot 2720 disposed one side of opening2558 and the suture 2700 extending through the opening 2558, as shown inFIG. 44B. Ends 2710 of suture 2700 may be installed on spring arms 2550via urging suture 2700 between fingers 2554, 2556 from the free endsthereof sufficiently so as to permit entry of ends 2710 of suture 2700into openings 2558. In use, upon retrieval of ends 2710 of suture 2700,ends 2710 are translated proximally with sufficient urging such thatknot 2720 displaces fingers 2554, 2556, allowing knot 2720 to movethrough opening 2558, thereby disengaging the end 2710 of suture 2700from its respective spring arm 2550.

Referring to FIGS. 45A-45B, another wound closure device 2800 providedin accordance with the present disclosure is shown generally as woundclosure device 2800. Wound closure device 2800 includes an elongatedshaft 2810 and a plunger 2820 slidably received within shaft 2810. Apair of selectively deployable arms 2830, 2840 is operably coupled toshaft 2810 and plunger 2820 and a pair of selectively deployable needleguides 2850, 2860 is operably coupled to shaft 2810. Wound closuredevice 2800 further includes a needle assembly having first and secondflexible needles 2910, 2920, respectively, which may be engaged toplunger 2820 for movement therewith, similar to wound closure device 500(FIGS. 11A-11B), or may be manually advancable/retractable, similar toneedle assembly 310 (FIG. 4).

Shaft 2810 is configured for insertion through a wound or other openingin tissue and defines a longitudinal bore 2812 extending therethroughthat is configured to slidably receive plunger 2820. First and secondarms 2830, 2840 are pivotably coupled to shaft 2810 at the distal regionthereof. First and second needle guides 2850, 2860 are pivotably coupledto shaft 2810 near the distal region thereof but longitudinally-spacedfrom arms 2830, 2840, proximally thereof. Arms 2830, 2840 and guides2850, 2860 are selectively pivotable relative to shaft 2810 and inconcert with one another between a retracted position (FIG. 45A) and adeployed position (FIG. 45B). In the retracted position (FIG. 45A), arms2830, 2840 and guides 2850, 2860 are disposed within the outerdimensions of shaft 2810 to define a low-profile configuration thatfacilitates insertion and removal of wound closure device 2800. In thedeployed position (FIG. 45B), arms 2830, 2840 and guides 2850, 2860extend outwardly from shaft 2810. Shaft 2810 further defines first andsecond needle lumens 2870, 2880 disposed on either side of longitudinalbore 2812.

Plunger 2820 is slidably received within longitudinal bore 2812 of shaft2810 and includes a distal end cap 2822 disposed at the distal end ofplunger 2820, a first cam block 2824 proximally-spaced from distal endcap 2822, and a second cam block 2826 proximally-spaced from first camblock 2824. First cam block 2824 includes a pair of opposed cam surfaces2825 configured to contact cam surfaces 2832, 2842 of arms 2830, 2840,respectively, to pivot arms 2830, 2840 between the retracted anddeployed positions upon translation of plunger 2820 through shaft 2810.Similarly, second cam block 2826 includes a pair of opposed cam surfaces2827 configured to contact cam surfaces 2852, 2862 of guides 2850, 2860,respectively, to pivot guides 2850, 2860 in concert with arms 2830, 2840between the retracted and deployed positions upon translation of plunger2820 through shaft 2810. Alternatively, as opposed to cam surfaces,plunger 2820 may be coupled to arms 2830, 2840 and guides 2850, 2860 viaa rack and pinion engagement, similarly as detailed above with respectto wound closure device 100 (FIGS. 2A-2B).

Plunger 2820 is selectively translatable through and relative to shaft2810, as a result of the above-configuration, between a proximalposition (FIG. 45A), corresponding to the retracted position of arms2830, 2840 and guides 2850, 2860, and a distal position (FIG. 45B),corresponding to the deployed position of arms 2830, 2840 and guides2850, 2860. As shown in FIG. 45B, in the deployed position, guides 2850,2860 are directed towards arms 2830, 2840.

Needle lumens 2870, 2880 extend longitudinally through shaft 2810 andare disposed in communication with guides 2850, 2860. Flexible needles2910, 2920 are configured for insertion through needle lumens 2870, 2880and into respective guides 2850, 2860 which (when disposed in thedeployed position), direct flexible needle 2910, 2920, upon furtherdistal translation thereof, through tissue and towards arms 2830, 2840.Needles 2910, 2920 may be configured to deposit and/or retrieve aportion of suture to/from arms 2830, 2840 in any suitable manner, suchas those detailed above. Further, a suture (not shown) may be routedthrough wound closure device 2800 and/or arms 2830, 2840 for usetherewith in any suitable manner, such as those detailed above.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. While several embodiments of the disclosure have been shownin the drawings, it is not intended that the disclosure be limitedthereto, as it is intended that the disclosure be as broad in scope asthe art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

What is claimed is:
 1. A wound closure system, comprising: a woundclosure device, including: an elongated shaft defining a proximal regionand a distal region, the distal region of the shaft configured forinsertion into an opening in tissue; a proximal arm pivotably coupled tothe shaft in the proximal region of the shaft; a distal arm pivotablycoupled to the shaft in the distal region of the shaft and defining afirst surface and a second, opposite surface; at least one linkageextending through the shaft and coupling the proximal and distal arms toone another such that the proximal and distal arms are pivotablerelative to the shaft between a linear position, wherein the proximaland distal arms and the shaft are linearly aligned with one another, afirst pivoted position, wherein the proximal arm is pivoted in a firstdirection relative to the shaft to pivot the distal arm in a second,opposite direction relative to the shaft such that the first surface ispositioned adjacent an internal surface of tissue, and a second pivotedposition, wherein the proximal arm is pivoted in the second directionrelative to the shaft to pivot the distal arm in the first directionrelative to the shaft such that the second surface is positionedadjacent an internal surface of tissue; a sleeve including a proximalend, a distal end having a bifurcated portion, first and second needlelumens, and a central passage extending longitudinally therethrough, thecentral passage configured to receive the wound closure device, thefirst and second needle lumens extending longitudinally through thesleeve and the bifurcated portion at the distal end thereof on eitherside of the central passage; and a suture including a first portiondisposed about the first surface of the distal arm and a second portiondisposed about the second surface of the distal arm.
 2. The woundclosure system according to claim 1, wherein the central passageconfigured to receive the wound closure device for removably positioningthe sleeve about the wound closure device when the wound closure deviceis disposed in the linear position, the sleeve being distally slidableabout the shaft to retain tissue between the distal end of the sleeveand one of the first surface or the second surface of the distal armpositioned adjacent an internal surface of tissue.
 3. The wound closuresystem according to claim 2, further including a needle insertablethrough one of the first and second needle lumens, the needle defining adistal portion configured to retrieve at least one of the first portionor the second portion of suture disposed about the first surface and thesecond surface, respectively, of the distal arm positioned adjacent aninternal surface of tissue.
 4. The wound closure system according toclaim 3, wherein the first and second needle lumens define curvedconfigurations.
 5. The wound closure system according to claim 4,wherein the needle defines a curved configuration.
 6. The wound closuresystem according to claim 4, wherein the needle defines a flexibleconfiguration.
 7. The wound closure system according to claim 4, whereinthe needle defines a hooked distal end.
 8. The wound closure systemaccording to claim 1, wherein the at least one linkage includes at leastone cable coupling the proximal and distal arms to one another.